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在药品卫生学检验中,中西药品和各类营养滋补品经常检出各类霉菌。但哪些是产毒菌株并必须予以鉴定,尚不清楚。为此,对原通化地区十二个药厂生产的108份口服药品进行霉菌分离和鉴定。其中:中成药蜜丸29份,中药散剂7份,膏制剂2份,中药素片3份,中药糖衣片7份,胶囊剂18份,蜂皇浆口服液12份,其它制剂8份,胶丸1份,口服液体8份,硬胶囊1份,冲剂12份。一、检查步骤: (一)取样:称取检品10g或10ml,按《药品卫生检验方法》规定的霉菌总数计数方法进行操作。在108份样品中,有83份检出霉菌,染菌率达77%。(二)分类鉴定:按无菌手续从经26℃培养72h的虎红琼脂平板上挑取微量孢子,点植在家氏琼脂
In the pharmaceutical hygiene inspection, Chinese and Western medicines and various nutritious supplements are often detected in various types of mold. However, it is not clear which strains are toxigenic and must be identified. To this end, 108 oral medicines produced by 12 pharmaceutical companies in the original Tonghua area were subjected to mold isolation and identification. Including: 29 Chinese Medicinal Pills, 7 Chinese herbal powders, 2 ointment preparations, 3 Chinese herbal tablets, 7 Chinese sugar-coated tablets, 18 capsules, 12 oral liquids, 8 other preparations, and plastic One pill, 8 oral liquids, 1 hard capsule, and 12 granules. First, the inspection steps: (A) sampling: said to take the test product 10g or 10ml, according to the “hygiene inspection method” provisions of the mold count method of operation. Of the 108 samples, 83 were found to have mold, and the infection rate was 77%. (B) Classification and identification: According to the aseptic procedure, micro spores were picked from tiger red agar plates incubated at 26°C for 72 hours and spotted on agar agar.